System and method for providing a single use imaging device for medical applications

ABSTRACT

A system and methods for providing and reclaiming a single use imaging device for sterile environments is disclosed and described. The system may include a single use high definition camera used for general purpose surgical procedures including, but not limited to: arthroscopic, laparoscopic, gynecologic, and urologic procedures, may comprise an imaging device that is a sterile and designed to ensure single use. The imaging device may have a single imaging sensor, either CCD or CMOS, encased in a housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/317,630, filed on Mar. 25, 2010, which is hereby incorporated byreference herein in its entirety, including but not limited to thoseportions that specifically appear hereinafter, the incorporation byreference being made with the following exception: In the event that anyportion of the above-referenced provisional application is inconsistentwith this application, this application supercedes said above-referencedprovisional application.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

BACKGROUND

The disclosure relates generally to imaging devices used during surgicalprocedures to visualize a surgical area, and more particularly, but notnecessarily entirely, to a system and methods for providing andreclaiming single use imaging devices primarily for sanitizedenvironments.

Endoscopic surgery is experiencing rapid growth in the medical field.Endoscopy is a minimally invasive surgical procedure that is used toanalyze the interior of a body cavity or interior surfaces of an organby inserting a tubular member into the body cavity through a minor orminimal incision. A conventional endoscope is generally an instrumentwith a light source and an image sensor or device for visualizing theinterior of a body cavity. A wide range of applications have beendeveloped for the general field of endoscopes including, but notnecessarily limited to: arthroscope, angioscope, bronchoscope,choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope,esophagogastro-duodenoscope (gastroscope), laparoscope, laryngoscope,nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and utererscope(hereinafter referred to generally as “endoscope”). The advantages ofendoscopy include smaller surgical incisions and less soft tissuedamage. As a result, there is significantly less discomfort and pain forthe patient as well as a decrease in recovery time.

The advantages of minimally invasive surgery performed with the help ofan endoscope are well known and understood in the medical field. As aresult, there have been a growing number of devices for use withendoscopes for delivering, for example, diagnostic, monitoring,treatment, operating instruments, tools, and accessories (collectively,“tools”) into the observation field and working space of the physician'sendoscope.

As part of forming an image of the surgical site, the endoscope includesa light source and an image sensor. Endoscopes may also incorporate morethan one tubular member for observation or operation within the body,such as a working channel for passing diagnostic, monitoring, treatment,or surgical tools through the endoscope. Endoscopes include glass lensesand an adjustable ocular or eye piece, a lateral connection for a lightconductor, an adaptor that allows focusing, and a camera head. Thisconfiguration is also called a video endoscope.

Additionally, imaging devices are subject to governmental regulations,for example the FDA in the United States, to protect patients andsurgeons from potential infections. These devices may be made andprocessed in accordance and consistent with international and nationalregulations for medical environments. The disclosure is directed to asystem and method for serializing a medical device, specifically animaging device such as a camera head.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e.,operating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the endoscope and itsattachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms; or the sterilefield may be considered an area immediately around a patient that hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In recent years there has been a trend of providing a single useendoscope and components as a packaged, sterilized product, similar to apackage containing a surgical implant, such as a knee or hip implant. Interms of endoscopy, instead of using endoscopes that have beenreconditioned for each new surgery through traditional sterilizationprocedures, it means using a single use endoscope and components thatare delivered to the hospital in a sterilized package. Due to thistrend, it has become increasingly difficult to ensure that eachendoscope and its components are properly cared for, used and sterilizedfor single use and not simply re-sterilized using traditionalsterilization procedures.

Traditional drawbacks or problems of video endoscopes include a lack ofimage quality, the need for sterilization and high manufacturing cost aswell as high processing cost. To address these and potentially otherproblems, the disclosure utilizes unique imaging devices or sensors inaddition to a unique method, system and process for providing andreclaiming single use imaging devices.

The features and advantages of the disclosure will be set forth in thedescription that follows, and in part will be apparent from thedescription, or may be learned by the practice of the disclosure withoutundue experimentation. The features and advantages of the disclosure maybe realized and obtained by means of the instruments and combinationsparticularly pointed out herein.

SUMMARY OF THE DISCLOSURE

An embodiment may comprise a single use camera used for general purposesurgical procedures including, but not limited to: arthroscopic,laparoscopic, gynecologic, and urologic. An embodiment may comprise animaging device that is a sterile and designed to ensure single use. Anembodiment may be an imaging device that comprises a single imagingsensor, either CCD (charge coupled device) or CMOS (complementary metaloxide semiconductor), encased in a molded plastic housing. It will beappreciated that the housing may be made from metal, carbon fiber orother suitable materials usable as an imaging device housing. Theimaging device may further comprise the means to be attached to anoptical coupling device, using C-Mount and CS-Mount threads or anotherproprietary or unique connection method. It is within the disclosure toinclude integrated optical systems, such that no specific coupling meansis required. The imaging device may further comprise a cable or wirelessmethod to transmit data to and from a camera control unit. An embodimentmay further comprise a thermal energy dissipation means such as a heatsink or cooling mechanism. An embodiment may further comprise anelectrically isolated imaging device, for example a camera head.

In an embodiment, information will be recorded in the memory of theimaging device each time it is used in a procedure or quality control(QC) checked at the manufacturer. This information may be used toevaluate usage time, expiration date, etc. An embodiment may comprisefeatures to ensure that the imaging device is only used once and thatthe imaging device is safe for use.

In an embodiment, the imaging device may be fully covered in plastichaving a sensor heat sink to ensure the camera head meets cardiacfloating (CF) and body floating (BF) ISO standards. It will beappreciated that the imaging device may be fully covered in metal,carbon fiber or other suitable materials usable as an imaging devicehousing. An embodiment may comprise an imaging device that may bestamped with the current time when plugged into a console in the fieldafter a quality control check has been performed. This time may be usedas a baseline for usage. If the imaging device is powered off for apredetermined period of time, which may be equivalent to a sterilizationcycle, then the imaging device will not function. The imaging device maydisplay an onscreen message telling the user that the camera has alreadybeen used and will not allow current operation. These features ensurethe imaging device will not be used more than one time per sterilizationcycle and further ensures that proper sterilization is performed by themanufacturer or other authorized source. This function is to protect thepatient and the doctor from an invalid or unsafe use as well asliability of the manufacturer.

In an embodiment an active imaging device may be attached to a controlunit. The control unit will check the last sterilization date and ensurethat the imaging device is no older than a predetermined safety date. Ifthe imaging device is older than the required date, an onscreen warningwill tell the user that the imaging device has expired and is unsafe foruse. These features will protect the patient and the doctor from using anon-sterile imaging device.

In an embodiment a security code or some other means of identifying, andvalidating for use, an imaging device by a control unit may be providedin order to verify that the imaging device is authorized for use. Avalidating security code or procedure of validation may be distributedto control units from a central database over the internet, by directtransfer from portable storage device such as USB device containingmemory, another computer, or other storage device.

An embodiment may comprise methods for processing single use cameraheads including quality control checking, functionality checking,sanitization or sterilization, packaging, transporting, use andreclamation, and reading and writing to memory within the imagingdevice. An embodiment may comprise a network of components, and mayfurther comprise the ability to update the imaging devices.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the disclosure will become apparent froma consideration of the subsequent detailed description presented inconnection with the accompanying drawings in which:

FIG. 1 is an illustration of an embodiment of the features of thedisclosure and made in accordance with the teachings and principles ofthe disclosure;

FIG. 2 is an illustration of an embodiment of an imaging system made inaccordance with the teachings and principles of the disclosure;

FIG. 3 is an illustration of an imaging system having wireless featuresmade in accordance with the teachings and principles of the disclosure;

FIG. 4 is an illustration of an embodiment of a control unitdisconnected from an imaging device, but illustrated as remainingconnected to complementary apparatuses, and made in accordance with theteachings and principles of the disclosure;

FIG. 5 is an illustration of an embodiment of a control unit displaymade in accordance with the teachings and principles of the disclosure;

FIG. 6 is an illustration of an embodiment of a retractable display of acontrol unit in a retracted or closed position and made in accordancewith the teachings and principles of the disclosure;

FIG. 6A is an illustration of an embodiment of a retractable display ofa control unit in an open position and made in accordance with theteachings and principles of the disclosure;

FIG. 7 is a cross-sectional view of an embodiment of an imaging devicehead made in accordance with the teachings and principles of thedisclosure;

FIG. 8 is a cross-sectional view of an embodiment of an imaging devicehead made in accordance with the teachings and principles of thedisclosure;

FIG. 9 is a cross-sectional view of an embodiment of an imaging devicehead made in accordance with the teachings and principles of thedisclosure;

FIG. 10 is a cross-sectional view of an embodiment of an imaging devicehead having a ball joint made in accordance with the teachings andprinciples of the disclosure;

FIG. 11 is a cross-sectional view of an embodiment of an imaging devicehead made in accordance with the teachings and principles of thedisclosure;

FIG. 12 is a layout view of an embodiment of an imaging system made inaccordance with the teachings and principles of the disclosure;

FIG. 13 is a schematic diagram of a memory of an embodiment of animaging system made in accordance with the teachings and principles ofthe disclosure;

FIG. 14 illustrates an embodiment of a method of using an imaging systemin accordance with the teachings and principles of the disclosure;

FIGS. 15 and 15A illustrate embodiments of a method of renewing andreclaiming an imaging device in accordance with the teachings andprinciples of the disclosure;

FIG. 16 illustrates an embodiment of a method of use in accordance withthe teachings and principles of the disclosure;

FIG. 17 illustrates an embodiment of a method of use according to theteachings and principles of the disclosure;

FIG. 18 illustrates an embodiment of a method of reclaiming an imagingdevice after use according to the teachings and principles of thedisclosure;

FIG. 19 illustrates an embodiment of a method of making an imagingdevice for use in a sterilized environment according to the teachingsand principles of the disclosure;

FIG. 20 illustrates an embodiment of a method for updating an imagingdevice system;

FIG. 21 illustrates an embodiment of a system for providing updates toan imaging system;

FIG. 22 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical imaging device in accordance with theteachings and principles of the disclosure;

FIG. 23 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical imaging device made in accordance with theteachings and principles of the disclosure;

FIG. 24 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical imaging device;

FIG. 25 illustrates an embodiment of a system for the reprocessing of asurgical imaging device;

FIG. 26 illustrates an embodiment of a system for the reprocessing of asurgical imaging device and providing updates for said imaging device;

FIG. 27 illustrates an embodiment of a system for the reprocessing of asurgical imaging device and providing updates for said imaging device;

FIG. 28 illustrates an embodiment of a system for updating a surgicalimaging device;

FIG. 29 illustrates an embodiment of a system for providing updates to asurgical imaging device;

FIG. 30 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical imaging device in accordance with theteachings and principles of the disclosure; and

FIGS. 31-33 illustrate embodiments of a method and system for processingmedical electronic imaging devices in accordance with the teachings andprinciples of the disclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles inaccordance with the disclosure, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the disclosure is thereby intended. Anyalterations and further modifications of the inventive featuresillustrated herein, and any additional applications of the principles ofthe disclosure as illustrated herein, which would normally occur to oneskilled in the relevant art and having possession of this disclosure,are to be considered within the scope of the disclosure claimed.

Before the devices, systems, methods and processes for providing andreclaiming single use imaging devices are disclosed and described, it isto be understood that this disclosure is not limited to the particularembodiments, configurations, or process steps disclosed herein as suchembodiments, configurations, or process steps may vary somewhat. It isalso to be understood that the terminology employed herein is used forthe purpose of describing particular embodiments only and is notintended to be limiting since the scope of the disclosure will belimited only by the appended claims, if any, and equivalents thereof.

In describing and claiming the subject matter of the disclosure, thefollowing terminology will be used in accordance with the definitionsset out below.

It must be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the context clearly dictates otherwise.

As used herein, the terms “comprising,” “including,” “containing,”“characterized by,” and grammatical equivalents thereof are inclusive oropen-ended terms that do not exclude additional, unrecited elements ormethod steps.

As used herein, the phrase “consisting of” and grammatical equivalentsthereof exclude any element, step, or ingredient not specified in theclaim.

As used herein, the phrase “consisting essentially of” and grammaticalequivalents thereof limit the scope of a claim to the specifiedmaterials or steps and those that do not materially affect the basic andnovel characteristic or characteristics of the claimed disclosure.

As used herein, the term “active” as used in relation to a device or toelectronic communication refers to any device or circuit, driven byhardware or software, that has decision making or logic processingcapabilities regarding its operation and/or its condition. Conversely,the term “passive” as used in relation to an imaging device or toelectronic communication refers to a hardware device that is written toand read from only, or a device that does not have any memory or otherelectronic, or physical tracking components and does not include anydecision making or logic processing capabilities regarding its operationand/or its condition.

With reference primarily to FIG. 1, an embodiment of the features of thedisclosure will be discussed generally. FIG. 1 illustrates a system 100for providing a digital image using a remote imaging device 110 that maybe tethered electronically and physically to a control unit 120. Thecontrol unit 120 may be configured to exchange data with imaging device110 in order to provide single use functionality and safety in a sterileenvironment, such as an operating room, a doctor's office or dentaloffice. Additionally, the control unit 120 may be electrically connectedto a computer 130 or external monitor 140 for increased functionality.

Referring now to FIG. 2 where the imaging system 100 will be discussedin greater detail. As is illustrated in FIG. 2, the imaging device 110can be connected or disconnected from the control unit 120 by way of anelectronic connector 114 on the imaging device 110 that is configured toelectronically and physically interact with a corresponding electronicconnector 126 on the control unit 120. The ability to disconnect theimaging device 110 from the control unit 120 provides the ability toeasily replace a used imaging device 110 for a sterilized, renewedimaging device 110. The imaging device 110 may have a head portion 112generally positioned remotely from the electronic connector 114, therebyallowing greater mobility of the head portion 112 during use.

Also illustrated in FIG. 2 is an embodiment of the control unit 120having an electronic connector 126 therein for receiving thecorresponding electronic connector 114 of the imaging device 110. Thecontrol unit 120 may also have a display 128 for conveying informationduring a procedure to an operator or user. The display 128 may alsocomprise interactive functionality allowing an operator to entercommands or change what information is being displayed. Suchfunctionality may be provided by a touch screen system as is commonlyknown. The control unit may also have video inputs 122 and video outputs124 for transferring image data to other apparatuses for increasedfunctionality. As illustrated in FIG. 1, common apparatuses may be acomputer 130 or an external monitor 140.

Referring now to FIG. 3 an imaging system 300 will be discussed havingwireless capability and features. As is illustrated in FIG. 3, theimaging device 310 may communicate with a control unit 320 by way ofwireless transmissions such as Wifi, infrared, bluetooth etc. Otherforms of wireless non-tethered connectivity may also be used forproviding communication between the imaging device 310 and control unit320, including but not limited to, radio frequency from any availablespectrum, infrared of all configurations, ultrasonic, and optical. Theimaging device 310 may comprise a head portion 312 that houses animaging sensor, memory and associated circuitry, which will be discussedin greater detail below. It will be appreciated that in a surgicalapplication, the quality of an image and the ability to adequately viewthe surgical site is a priority for a surgeon.

The imaging sensor used in the camera head may be a single sensor. Dueto the ability to make smaller sized sensors, the single sensor may belocated or positioned anywhere along the endoscope. For example, thesensor may be located or positioned proximally with respect to theendoscope, or at the distal end of the endoscope without departing fromthe spirit or scope of the disclosure. In an embodiment, the imagingsensor may be located on a tip of a device, i.e., in a chip-on-the-tipconfiguration, such as on the distal end of an endoscope or othercomponent.

It will be appreciated that the imaging sensor may be a combination orplurality of sensors that work together to create a three-dimensionalimage. The single imaging sensor or the combination or plurality ofimaging sensors may be high definition sensors for purposes of creatinga high quality image, such that images may be viewed in a highresolution, for example 1920×1080 pixels or any other high definitionstandard, such as 1280×720 pixels.

The image sensor may be located on a rigid endoscopic member or aflexible endoscopic member. For example, the image sensor may be locatedon a distal end of an articulating member, such that the sensor mayarticulate or move for better positioning within a surgical site. Insuch a case, the camera may be a flexible camera head. It will beappreciated that as the imaging sensor is located closer to the distalend of the endoscope, visualization may be improved. Improvedvisualization may be due to the amount of light available for the sensorto create an image when the sensor is located distally with respect tothe endoscope. Because the location of the sensor may be closer to wherethe light is being concentrated or focused there may be improvedvisualization. Thus, in various embodiments, the imaging sensor may belocated on a distal end of the endoscope. Further, the imaging sensormay used in a multi-port or single port surgical application. In asingle port application, there may be multiple channels through whichflexible and rigid instrument delivery tubes are inserted.

The head portion 312 may further comprise a wireless transceiver 314 forcommunicating with a corresponding wireless transceiver 322 housed inthe control unit 320. The ability to separate the head portion 312 fromthe control unit 320 via wireless transmissions may provide for the easyreplacement of used imaging devices for sterilized and renewed imagingdevices. In other words, the wireless communication may be enabled by anelectronic communication circuit that is a wireless communicationtransceiver configured to communicate wirelessly with a correspondingtransceiver on said control unit using any of the above noted wirelesstechnologies. The wireless functionality also allows for greatermobility of the head portion 312 during use. It will be appreciated thatthe wireless features and functionality may be incorporated into any ofthe embodiments disclosed herein or embodiments that fall within thescope of this disclosure.

Also illustrated in FIG. 3 is an embodiment of the control unit 320having wireless capabilities and features. A transceiver 322 may beprovided in or as part of the control unit 320 for receiving andtransmitting wireless data to the imaging device 310. The control unit320 may also have a display 328 for conveying information during aprocedure to an operator or user. The display 328 may also compriseinteractive functionality allowing an operator to enter commands orchange what information is being displayed. Such functionality may beprovided by a touch screen system as is commonly known. The control unit320 may also have video inputs 321 and video outputs 324 fortransferring image data to other apparatuses for increasedfunctionality. As illustrated in FIG. 1 common apparatuses may be acomputer 130 or an external monitor 140. It is within the scope of thisdisclosure to include an imaging system comprising both wired andwireless communication capabilities.

Illustrated in FIG. 4 is an embodiment of the control unit 420disconnected from an imaging device that is illustrated as beingconnected to complementary apparatuses. A connector 426 may be providedtherein for transferring data to and from an imaging device. The abilityto separate the imaging device may provide for the easy replacement ofused imaging devices with sterilized and renewed imaging devices. Thecontrol unit 420 may also have a display 428 for conveying to anoperator information during a procedure. The display 428 may alsocomprise interactive functionality allowing an operator to entercommands or change what information is being displayed. Suchfunctionality may be provided by a touch screen system as is commonlyknown. The control unit may also have video inputs 421 and video outputs424 for transferring image data to other apparatuses for increasedfunctionality. Common apparatuses may be a computer 430 or an externalmonitor 440 there by increasing the technical functionality of thesystem 400. A computer 430 may be used for storing the digital outputfrom the imaging system or may be used to enhance and provide furtheradjustment within the system. An external monitor 440 may be used toshow real time digital images to aid an operator in the use of thesystem, or later review and study the recorded digital imagery.

Referring now to FIG. 5 an embodiment of a control unit display 428 thatmay be part of a control unit 420 will be discussed in greater detail.The display 428 may be a digital display of liquid crystal design (LCD),or the display may be some other technology beside LCD, and may havetouch screen functionality and capability for an operator or user toinput commands into the system 400. The embodiment discussed herein mayhave input portions 428 a and 428 b whereby an operator or user mayinput commands into the system 400. The embodiment may further comprisea status portion 428 c informing a user about the operational status ofthe components of the system 400. For example, display portion 428 c maydisplay an error message related to the condition of an attached imagingdevice 410 if the imaging device 410 has already been used or has beendeemed unfit for a procedure. The display 428 may also have a dedicatedmessage portion 428 d providing instructions and further information toan operator or user. The configuration of the display 428 may changeduring use to accommodate further functionality. A plurality of displays428 is contemplated by, and falls within the scope of, this disclosureand may be used alternatively or in conjunction with this embodiment. Anembodiment may comprise a key pad or a button pad for control purposeswithin a control unit.

Illustrated in FIGS. 6 and 6A is an embodiment of a retractable display428 of a control unit 420. The display 428 may have a first or retractedposition within the control unit 420 (illustrated best in FIG. 6) thatmay be used to protect the display 428 when it is not being used. Thedisplay 428′ of FIG. 6A illustrates how the display may be deployed intoa more user readable position, as it has been extended and rotatedoutward. As illustrated in FIGS. 6 and 6A, the display may be slid inand out of a passage and rotated about an axis to orient the display 428in a wide range of positions.

Illustrated in FIG. 7 is a cross-sectional view of an embodiment of animaging device head 712. The imaging device head 712 may comprise ahousing 710 made of a suitably rigid material, such as plastic or metal.The housing 710 may be sealed against fluids and gases so as to protectthe internal circuitry and provide a suitable surface for sterilizationand renewal. The imaging device head 712 may further comprise a userinput panel 720 having buttons 721 and 722 for operation of the imagingdevice head 712. Additional, buttons may be provided and thefunctionality of the buttons can be customized for a given procedure ora given operator. The control panel 720 may be internally connected toother circuitry of the imaging device head 712 by an electricalconnector 726.

As illustrated further in FIG. 7, imaging device head 712 may comprisean optical mount system 750, such as a C-mount system for receivingthreaded accessories, for example one inch threaded accessories. Awindow 755 may also be incorporated into the embodiment for facilitatingthe transmission of light from an optical accessory to an image sensor775. The image sensor 775 may be mounted to a supporting printed circuitboard or supportive substrate 770. An electronic connector 778 may beincorporated to electronically connect the image sensor 775 to a maincircuit or main printed circuit board 760. A main wiring harness 782 maybe incorporated into a wired tether 780 thereby electrically connectingthe components of the imaging device head 712 to a control unit.

The imaging device head 712 may further comprise a memory 788 or memorycircuit allowing the storage of data within the imaging device head 712.It will be appreciated that memory may be any data storage device thatis capable of recording (storing) information (data). Data that may bestored or written into memory 788 may include an identifying serialnumber that uniquely identifies an imaging device. Other data that maybe stored or written into memory 788 may include data such as the amountof the time the imaging device has been used, i.e., the hours ofoperation, or the amount of time the imaging device has been powered on.Data that may be written into memory 788 may include sterilization dataor renewal data, representing the working condition of the imagingdevice. Data that may be stored or written into memory 788 may includedata such as manufacturing date, date of last verification or qualitycontrol check, location of manufacture, i.e., may include name, city,state, street address and so forth, last control unit that the imagingdevice head was attached to, imaging device head diagnostic information,specific procedural settings for the imaging device head, or preferredsettings for an operator or user, such as a surgeon. Data representingthe above characteristics, or other indicia, of the imaging device maybe recorded into memory within the imaging device.

The memory 788 may be encryption protected so as to avoid tampering orunintended use and foreseeable misuse. It should be noted that a memory788 may be placed anywhere in the imaging device and not just theimaging device head without departing from the scope of the disclosure.The memory 788 may comprise a permanent or semi-permanent portionallowing varying degrees of data durability.

Illustrated in FIG. 8 is a cross-sectional view of an embodiment of animaging device head 812. The imaging device head 812 may comprise ahousing 810 made of a suitably rigid material such as plastic or metal.The housing 810 may be sealed against fluids and gases so as to protectthe internal circuitry and provide a suitable surface for sterilizationand renewal. The imaging device head 812 may further comprise a userinput panel 820 having buttons 821 and 822. Additional, buttons may beprovided and the functionality of the buttons can be customized for agiven procedure and or a given operator. The control panel 820 may beinternally connected to other circuitry of the imaging device head 812by an electrical connector 826.

As illustrated further in the embodiment of FIG. 8, the imaging devicehead 812 may comprise an optical mount system 850, such as a C-mountsystem for receiving threaded accessories, for example one inch threadedaccessories. A window 855 may also be incorporated into the embodimentfor facilitating the transmission of light from an optical accessory toan image sensor 875. The image sensor 875 may be mounted to a supportingprinted circuit board or supportive substrate 870. An electronicconnector 878 may be incorporated to electronically connect the imagesensor 875 to a main circuit or main printed circuit board 860. In orderto provide heat dissipation from the image sensor 875 and othercircuitry, a heat sink 861 may be provided. The heat sink 861 may bephysically connected to the image sensor 875 and it may also beconnected to the housing 810, such that heat energy can be conducted ortransferred to the external portion of the imaging device head 812. Theheat sink 861 may be a neutral sensor heat sink exposed externally toensure the camera head meets cardiac floating (CF) and body floating(BF) ISO standards. An embodiment of the heat sink 861 may be made ofaluminum and have fins for added heat transfer surface area. A mainwiring harness 882 may be incorporated into a wired tether 880 therebyelectrically connecting the components of the imaging device head 812 toa control unit.

The imaging device head 812 may further comprise a memory 888 or memorycircuit allowing the storage of data within the imaging device head 812.Data that may be stored or written into memory 888 may include anidentifying serial number that uniquely identifies an imaging device.Other data that may be stored or written into memory 888 may includedata such as the amount of the time the imaging device has been used,i.e., the hours of operation, or the amount of time the imaging devicehas been powered on. Data that may be written into memory 888 mayinclude sterilization data or renewal data, representing the workingcondition of the imaging device. Data that may be stored or written intomemory 888 may include data such as manufacturing date, date of lastverification or quality control check, location of manufacture, i.e.,may include name, city, state, street address and so forth, last controlunit that the imaging device head was attached to, imaging device headdiagnostic information, specific procedural settings for the imagingdevice head, or preferred settings for an operator or user, such as asurgeon. Data representing the above characteristics, or other indicia,of the imaging device may be recorded into memory within the imagingdevice.

The memory 888 may be encryption protected so as to avoid tampering orunintended use and foreseeable misuse. It should be noted that a memorymay be placed anywhere in the imaging device and not just the imagingdevice head without departing from the scope of the disclosure. Thememory 888 may comprise a permanent or semi-permanent portion allowingvarying degrees of data durability.

Illustrated in FIG. 9 is a cross-sectional view of an embodiment of animaging device head 912. The imaging device head 912 may comprise ahousing 910 made of a suitably rigid material such as plastic or metal.The housing 910 may be sealed against fluids and gases so as to protectthe internal circuitry and provide a suitable surface for sterilizationand renewal. The imaging device head 912 may further comprise a userinput panel 920 having buttons 921 and 922. Additional, buttons may beprovided and the functionality of the buttons can be customized for agiven procedure and or a given operator. The control panel 920 may beinternally connected to other circuitry of the imaging device head 912by an electrical connector 926.

As illustrated further in the embodiment of FIG. 9, the imaging devicehead 912 may comprise an optical mount system 950, such as a C-mountsystem for receiving threaded accessories, for example one inch threadedaccessories. A window 955 may also be incorporated into the embodimentfor facilitating the transmission of light from an optical accessory toan image sensor 975. The image sensor 975 may be mounted to a supportingprinted circuit board or supportive substrate 970. An electronicconnector 978 may be incorporated to electronically connect the imagesensor 975 to a main circuit or main printed circuit board 960. In orderto provide heat dissipation from the image sensor 975 and othercircuitry, a heat sink may be provided, similar to the heat sinkprovided in FIG. 8. The heat sink may be physically connected to theimage sensor 975 and it may also be connected to the housing 910, suchthat heat energy can be conducted or transferred to the external portionof the imaging device head 912. A main wiring harness 982 may beincorporated into a wired tether 980 thereby electrically connecting thecomponents of the imaging device head 912 to a control unit.

The imaging device head 912 may further comprise a memory 988 or memorycircuit allowing the storage of data within the imaging device head 912.Data that may be stored or written into memory 988 may include anidentifying serial number that uniquely identifies an imaging device.Other data that may be stored or written into memory 988 may includedata such as the amount of the time the imaging device has been used,i.e., the hours of operation, or the amount of time the imaging devicehas been powered on. Data that may be stored or written into memory 988may include data such as manufacturing date, date of last verificationor quality control check, location of manufacture, i.e., may includename, city, state, street address and so forth, last control unit thatthe imaging device head was attached to, imaging device head diagnosticinformation, specific procedural settings for the imaging device head,or preferred settings for an operator or user, such as a surgeon. Datarepresenting the above characteristics, or other indicia, of the imagingdevice may be recorded into memory within the imaging device.

The memory 988 may be encryption protected so as to avoid tampering orunintended use and foreseeable misuse. It should be noted that a memorymay be placed anywhere in the imaging device and not just the imagingdevice head without departing from the scope of the disclosure. Thememory 988 may comprise a permanent or semi-permanent portion allowingvarying degrees of data durability.

The imaging device head 912 may comprise a ball joint 990 with acorresponding seal and socket, thereby providing increased mobilitybetween the housing 910 and the tether 980 during articulation of theimaging device by an operator or user.

With reference primarily to FIG. 10, an embodiment of an imaging deviceball joint 990 will be discussed in further detail. FIG. 10 isillustrative of a cross-sectional view of a ball joint 990, whichprovides greater freedom of articulation for an operator when moving theimaging device head 912 relative to the wiring tether 980. The balljoint 990 may comprise a substantially spherical rotatable portion orball 991. The ball 991 may be configured to mechanically operate incommunication with a corresponding socket 992, such that the ball 991may substantially freely rotate while being retained within the socket992. A seal may be provided withing the ball joint 990 by the inclusionof a seal ring 993. The seal ring 993 may also provide mechanicalresistence within the ball joint 990. The ball 991 may further includean opening 994 therethrough allowing wiring 995 to pass through the balljoint 990.

With reference to FIG. 11, an embodiment of an imaging device 1100comprising wireless transmission functionality will be discussed. Across-sectional view of an embodiment of an imaging device head 1112 isshown in FIG. 11. The imaging device head 1112 may comprise a housing1110 made of a suitably rigid material such as plastic or metal. Thehousing 1110 may be sealed against fluids and gases so as to protect theinternal circuitry and provide a suitable surface for sterilization andrenewal. The imaging device head 1112 may further comprise a user inputpanel 1120 having buttons 1121 and 1122. Additional, buttons may beprovided and the functionality of the buttons can be customized for agiven procedure and or a given operator. The control panel 1120 may beinternally connected to other circuitry of the imaging device head 1112by an electrical connector 1126. The imaging device head 1112 maycommunicate with a control unit by way of wireless transmissions such asWifi, infrared, bluetooth etc. Other forms of wireless non-tetheredconnectivity may also be used for providing communication between theimaging device head 1112 and the control unit, including but not limitedto, radio frequency from any available spectrum, infrared of anyconfiguration, ultrasonic, and optical. As illustrated further in theembodiment of FIG. 11, the imaging device head 1112 may comprise anoptical mount system 1150, such as a C-mount system for receivingthreaded accessories, for example one inch threaded accessories. Awindow 1155 may also be incorporated into the embodiment forfacilitating the transmission of light from an optical accessory to animage sensor 1175. The image sensor 1175 may be mounted to a supportingprinted circuit board or supportive substrate 1170. An electronicconnector 1178 may be incorporated to electronically connect the imagesensor 1175 to a main circuit or main printed circuit board 1160. Thecircuitry of the imaging device head 1112 may electrically be connectedto a wireless transceiver 1111 for transmitting and receiving data froma wirelessly configured control unit as illustrated in FIG. 3.

The imaging device head 1112 may further comprise a memory 1188 ormemory circuit allowing the storage of data within the imaging devicehead 1112. Data that may be stored or written into memory 1188 mayinclude an identifying serial number that uniquely identifies an imagingdevice. Other data that may be stored or written into memory 1188 mayinclude data such as the amount of the time the imaging device has beenused, i.e., the hours of operation, or the amount of time the imagingdevice has been powered on. Data that may be stored or written intomemory 1188 may include data such as manufacturing date, date of lastverification or quality control check, location of manufacture, i.e.,may include name, city, state, street address and so forth, last controlunit that the imaging device head was attached to, imaging device headdiagnostic information, specific procedural settings for the imagingdevice head, or preferred settings for an operator or user, such as asurgeon. Data representing the above characteristics, or other indicia,of the imaging device may be recorded into memory within the imagingdevice.

The memory 1188 may be encryption protected so as to avoid tampering orunintended use and foreseeable misuse. It should be noted that a memorymay be placed anywhere in the imaging device and not just the imagingdevice head without departing from the scope of the disclosure. Thememory 1188 may comprise a permanent or semi-permanent portion allowinga varying degrees of data durability.

It will be appreciated that the ball joint illustrated in FIGS. 9 and 10may be used by any embodiment of the disclosure without departing fromthe spirit or scope of the disclosure. Thus, for example, the ball joint990 may be used with imaging device head 712, 812, 912, or 1112.Similarly, it will be appreciated that the heat sink 861 (illustrated inFIG. 8) may be used by any embodiment of the disclosure withoutdeparting from the scope of the disclosure.

Referring now to FIG. 12 an embodiment of a system for acquiring imageryin a sterilized environment will be discussed. The system may comprisean imaging device 1201 having a memory 1202, an image sensor 1204, andsupporting circuitry 1206, including a processor. The imaging device1201 may be an active device and may comprise a processor, amicro-processor or micro controller, a field programmable gate array(FPGA), active circuit, or a complex programmable logic device (CPLD).The system may further comprise and control unit 1220 having a processor1221, time circuit or realtime clock 1222, a counting or incrementingcircuit 1224 and a control unit memory 1226. The components willgenerally be provided in a housing, but are shown hear in block diagramform for simplicity and discussion purposes. It is contemplated that anyof the above circuits can operate from either a control unit or animaging device.

As can be seen in FIG. 13 the memory 1202 of the imaging device 1201 maycomprise the following arrays of data storage:

a. Hours of camera head operation;

b. Number of times camera has been used;

c. Unique identification i.e. serial number, id, etc.;

d. Manufacture date;

e. Date of last verification/quality check;

f. Location of manufacture i.e. (Address, state, city etc.);

g. Last console that the camera head was connected to;

h. Camera console diagnostic information;

i. Procedural specific camera head settings (i.e. video settings, buttonsettings, etc.);

j. Last Sterilization date (used to ensure safety to product); and

k. Surgeon or user settings.

Additional data may be stored within the memory 1202 that would enhancethe imaging device and is considered to be within the scope of thedisclosure.

With reference to FIG. 14, a method of using an imaging systemconsistent with the embodiments disclosed herein will be discussed. Inuse, a sterilized single use imaging device 1201 will be provided thatmay comprise memory 1202 at 1410. At 1420 a user may connect the singleuse imaging device 1201 to a complementary control unit 1220 bothelectronically and physically. At 1430 the control unit 1220 mayinitiate a process of reading memory 1202 and registers the serialnumber of the imaging device 1201. At 1440 the system causes a value tobe recorded into memory 1202 indicating that the imaging device 1201 hasbeen used. At 1450 the system records into memory 1202 the date and timethe imaging device 1201 is connected to the control unit 1220. At 1460 atiming process is initiated by the control unit from the base line timerecorded at 1450 and tracks or times the duration that the imagingdevice 1201 is used and the duration is recorded into memory 1202 at1470. After use, the imaging device 1201 is disconnected from thecontrol unit 1220 at 1480 and then discarded for renewal or reclamation.

Referring now to FIGS. 15 and 15A, a method of renewing and reclaiming asingle use imaging device 1201 will be discussed. At 1510 the imagingdevice 1201 may be connected to a testing control unit or a mastercontrol unit. At 1515 the components of the imaging system may beauthenticated according to the teachings and principles of thedisclosure (see discussion in relation to FIG. 30 below). At 1520 thetesting control unit or master control unit causes the data stored inmemory 1202 to be recorded into storage on the testing control unit ormaster control unit as stored, in order for the specific imaging device1201 to be renewed. At 1525 a value is placed in memory 1202 indicatingthat the imaging device has been renewed and is ready for use such thatwhen connected to another control unit for use it will operate. Thelocation and date of the renewal may then be recorded into memory 1202at 1530. At 1540 the imaging device 1201 can be sterilized and (at 1550)placed in a protective sterilized package.

With reference to FIG. 16 an alternative embodiment of a method of usewill be discussed illustrating safety settings of the embodiment. At1610 the memory imaging device head may be stamped with time ofmanufacture when it is plugged into the master control unit or masterconsole after assembly in the field, i.e., in an operating room, andafter a quality control check has been performed. At 1620 a check may bemade to determine if the imaging device has been powered off for apredetermined number of minutes, such as a time frame that is close towhat a typical sterilization cycle would last. At 1630, if the imagingdevice has been powered off the predetermined amount of time the controlunit will display an onscreen message telling the user the imagingdevice has already been used, and will not allow further operation, suchthat no image will be produced through video feed. This feature willensure the imaging device, i.e., the camera, will not be used more thanone time per sterilization cycle. This feature also protects the patientand the doctor from an invalid or unsafe use and foreseeable misuse.

Referring to FIG. 17 an embodiment of a method of use will be discussed.During use, an imaging device may be connected to a control unit. Uponconnection, an electronic communication connection is formed between theimaging device and the control unit. At 1702 the imaging device may bepowered on by power supplied by the control unit. At 1704 a processor inthe control unit may cause data regarding imaging device identificationthat may be stored in a memory within the imaging device to be read. At1706 a processor in the control unit may cause data regarding themanufacturing date of the imaging device to be read from memory withinthe imaging device. The processor in the control unit may then comparethe data to a predetermined data value range. At 1707 an error messagemay be displayed if the read data is outside the predetermined datavalue range and the imaging device will be stopped from operating. At1708 a processor in the control unit may cause data regarding thereclamation of the imaging device to be read from memory within theimaging device. The data regarding reclamation of the imaging device mayinclude data representing whether or not the imaging device has beenpreviously used. The processor may then compare the data to apredetermined data value range. At 1709 an error massage may bedisplayed if the read data is outside the predetermined data value rangeand the imaging device will be stopped from operating. At 1710 aprocessor in the control unit may cause data regarding the reclamationdate of the imaging device to be read from memory within the imagingdevice. The processor may then compare the data to a predetermined datavalue range. At 1711 an error massage may be displayed if the read datais outside the predetermined data value range and the imaging devicewill be stopped from operating. At 1712 a processor in the control unitmay cause usage information of the current procedure to be monitored tonote whether imaging device has been unpowered for a predeterminedperiod of time and then re-powered. If this condition occurs it ispossible that the imaging device has been tampered with or that anattempt has been made to sterilize the imaging device and use it asecond time. The predetermined period of time may correspond to theamount of time a typical sterilization process would normally take. Theprocessor then compares the data to a predetermined data value range. At17013 an error massage may be displayed if the data read is outside thepredetermined data value range and the imaging device will be stoppedfrom operating. At 1714 a processor in the control unit may cause avalue to be placed in memory in the imaging device indicating that theimaging device has been used. At 1716 a processor in the control unitmay cause the date and time of use to be recorded in memory in theimaging device. Additional information may be recorded into the memoryof the imaging device such as, for example, duration of use, proceduresettings, and user settings and any other data suitable for recording tomemory. The imaging device may be disconnected from the control unit andthereby powered off at 1718.

Referring now to FIG. 18 a method of reclaiming an image device afteruse will be discussed. It should be noted that a single use imagingdevice may comprise the durability to be used a plurality of times,however sterilization requirements may prevent an imaging device frombeing used more than once without a process for reclaiming the imagingdevice, thereby returning it to a sterilized condition. A method ofreclamation for an imaging device may comprise the process of poweringon the imaging device at 1802, when the imaging device is electricallyconnected to a control unit. At 1804 a processor in the control unit maycause data representing identification information for the imagingdevice to be stored in storage in the control unit. A control unit maybe a master control unit configured for reclaiming the imaging devices.The master control unit may track a plurality of imaging devices therebykeeping a catalog of associated information such as use and condition ofthe device or devices. At 1806 a processor in the control unit may causethat data representing a manufacturing date to be read and compared to apredetermined value or range of values. If the read data is out of thepredetermined range value, an error report may be issued at 1807. At1808 a processor in the control unit may cause data representing usedata written in memory of the imaging device to be read and recordedinto storage in the control unit. At 1810 a processor may cause datarepresenting a date and time of reclamation to be recorded into memoryin the imaging device. At 1812 a processor in the control unit may causethat data representing the number of uses of the imaging device to beread and recorded into storage in the control unit. The processor maycompare the read data to a predetermined value or range of values todetermine whether the imaging device is fit for continued use. If thepredetermined value is exceeded an error message may be displayed (at1813) and the imaging device may be retired. At 1814 a processor in thecontrol unit may initiate a test or quality control check of all thecircuitry in the imaging device to ensure that the device is functional.At 1815 it may be determined that the imaging device failed the qualitycontrol check and an error massage may be displayed. At 1816 the imagingdevice can be reset for use. The resetting process may comprise writingdata to the memory of the imaging device indicating that the imagingdevice has been reclaimed and sterilized. At 1816 the device may bedisconnected from the control unit and physically sterilized andrepackaged.

With reference primarily to FIG. 19, an embodiment of a method formaking an imaging device having memory therein for use in a sterilizedenvironment will be discussed. At 1902 an imaging device may be poweredon upon being connected to a control unit. The control unit may be amaster control unit configured for the manufacturing process. At 1904 aprocessor in the control unit may cause that data representing anidentification serial number for the imaging device to be written intomemory of the imaging device. At 1906 a processor in the control unitmay cause that data representing the location of manufacture be recordedto memory in the imaging device. At 1908 a processor may cause that datarepresenting the date of manufacture may be recorded into memory on theimaging device. At 1910 a processor in the control unit may initiate atest or quality control check of all the circuitry in the imaging deviceto ensure that the device is functional. At 1912 the imaging device maybe unplugged from the control and sterilized for packaging.

Referring to an embodiment illustrated in FIG. 20, a system having asecurity code or some other means of identifying, and validating foruse, an imaging device by a control unit, in order to verify that theimaging device is authorized for use will now be described. A validatingsecurity code or procedure of validation may be distributed to controlunits from a central database over the internet, by direct transfer fromportable storage device such as USB device containing memory, anothercomputer, or other storage device.

With reference to FIG. 20, an embodiment of a method for providingupdates with in a medical imaging system will be discussed. At 2002 acontrol unit may be powered on to receive a security update. At 2004security update data may provided comprising validation codes thatcorrespond to imaging devices to be connected to the control unit. Suchvalidation codes may enable the system to insure that users of thesystem may be prevented from using imaging devices that have beenselected for non-use by a manufacturer or distributor. Selectioncriteria for non-use may include safety considerations, recallconsiderations, anti counterfeit measures, and sales and contractconsiderations. At 2006 the data may be transferred into storage ormemory of the control unit in order to provide that data for latercomparison to security codes provided by imaging devices. It is withinthe scope of this disclosure to include all means for transferring data,including but not limited to, transmission over a network, transfer viaon site transmission from a storage medium that is portable, such as adisk, memory drive, or short distance wireless transmission. At 2008 thesystem may be powered off.

With reference primarily to FIG. 21, an embodiment of an imaging systemhave the feature of updating data will be discussed. An imaging system2100 may comprise a control unit 2102 and a data server 2104. Thecontrol unit 2106 may be electronically in communication with the dataserver 2104 over a network such as the internet 2106. The control unit1202 may receive update data over the internet 2106 from data server2104. The control unit 2102 may also receive update data directly from amemory transfer device 2108 such as a memory stick, thumb drive, jumpdrive, hard drive, optical disk to name a few. The control unit 2102 mayalso receive update data from another computer or portable device 2110such as a PDA or laptop that is presented to the control unit 2102 onsite. Data transfer may be made with a physical connection and or by awireless transfer of data.

FIG. 22 illustrates an embodiment of a system and method for themanufacture and reprocessing of a surgical camera head or imagingdevice. Reprocessing may represent the reclaiming or recycling of a usedsurgical camera head and any associated accessories or components ofsaid surgical camera head and may be referred to individually orcollectively herein as an imaging device or a camera head. At 2202 thecamera head components are assembled into a working unit having memory.At 2204 the assembled camera head is checked for proper operation andquality to ensure the assembled camera head passes a pre-determinedminimum standard. At 2206 the camera head may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 2208. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 2210.

At 2212 the camera head may be tested for video quality and otheroperational standards. The inspection and testing of video quality andother operational standards may include a visual inspection of thevideo/image quality against a known, acceptable image standard. It willbe appreciated that this procedure may be automated, such that if theimage does not meet a certain pre-determined quality standard the onscreen check will return with a “use or no-use” or “go or no-go” onscreen reply or signal.

At 2214 the camera may be packaged in a container, such as a tray,pouch, bag or the like, which may be sterilized along with thecomponents within the container. Such containers may provide the abilityto sanitize the camera head while inside the container. This package orcontainer of components may then be sanitized or sterilized as noted at2216. It will be appreciated that in an embodiment, the componentsincluded in the container, such as a tray, pouch, bag or the like, mayalso include a biohazard bag or sanitation bag. The biohazard bag may beused after an imaging device and related components have been used orotherwise contaminated to return the used or contaminated imagingdevice, along with any components, to a reprocessing center or agent fordisinfection and further reprocessing treatment.

At 2216 the packaged camera head may then be sanitized or sterilized. Itwill be appreciated that there are many methods for sanitizing,sterilizing or otherwise eliminating (killing) transmissible agents,such as fungi, bacteria, viruses, bacterial spores, etc. from surgicaltools and equipment. Such methods are within the scope of thedisclosure. Sterilization may be accomplished using one or more of thefollowing heat, chemicals, irradiation, and high pressure systems.Examples of the sanitization or sterilization methods may includeethylene oxide, gamma radiation, chemicals and autoclave systems.

At 2218, the imaging device, i.e., camera head and any accompanyingcomponents, may be further packaged and shipped to an end user. Thecamera head may then be used for a surgical procedure where during theprocedure a camera control unit writes to the memory in the camera headwhere a use value or use bit may be set at 2220. After use orcontamination, the camera head may be placed in a return shippingcontainer suitable for biohazard shipping at 2222 and shipped to aprocessing facility or manufacturer at 2224. At 2226 the processingfacility or manufacturer may receive the used or otherwise contaminatedcamera head and, at 2228, the camera head may be unpackaged anddisinfected for further processing. It will be appreciated that thedisinfection process is for worker safety where handlers of the used orotherwise contaminated camera head wear protective clothing, such asgloves and gowns. The disinfection process may include chemicaltreatment of the used or otherwise contaminated imaging device or camerahead to meet low-level or other appropriate governmental standards fordisinfection. Various chemicals may be used for the initial disinfectionprocess and may include alcohols, aldehydes, and oxidizing agents. Itwill be appreciated that other disinfection processes may be used toinitially treat the used or otherwise contaminated camera head withoutdeparting from the scope of the disclosure.

At 2230 the camera head may be inspected to determined whethercomponents need to be replaced. If it is determined that some componentsof the camera head need to be replaced, then at 2232 the faultycomponents will be replaced. For example, components that may bereplaced include cables, imaging device connectors, and buttons.However, it should be noted that during this inspection all componentsmay be replaced on an as needed basis. After the faulty components havebeen replaced at 2232, the camera head may be checked for quality andfunctionality at 2204, and then further processed in accordance to theillustrated system.

It will be appreciated that the above system or method for themanufacture and reprocessing of a surgical camera head or imaging devicemay include details relating to the camera head itself or the variousprocesses within each step noted, which may be utilized by any of theembodiments disclosed herein and such details are incorporated into eachof the embodiments.

FIG. 23 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical camera head or imaging device. Reprocessingmay represent the reclaiming or recycling of a used surgical camera headand any associated accessories or components of said surgical camerahead. At 2302 the camera head components are assembled into a workingunit having memory. At 2304 the assembled camera is checked for properoperation and quality. At 2306 the camera head may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 2308. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 2310.

At 2312 the camera head may be tested for video quality and otheroperational standards. At 2314 the camera may be packaged in a biohazardbag or sanitation bag. Such bags may provide the ability to sanitize thecamera head while inside the bag. The sanitation process may include orbe accomplished using Ethylene-Oxide (EO) gas, or other fluid processcorresponding to the properties of said bag or packaging. At 2316 thepackaged camera head may then be sanitized. At 2318 the camera head maybe further packaged such as in a tray and shipped to an end user. Thecamera head may be then used for a surgical procedure where during theprocedure a camera control unit writes to the memory in the camera heada usage value at 2320. After use the camera head may be placed in areturn shipping container suitable for biohazard shipping at 2322 andshipped to a processing facility or manufacturer at 2324. At 2326 themanufacturer or processing facility may receive the used camera head andat 2328 the camera head may be unpackaged and disinfected for furtherprocessing. At 2330 the camera head may be inspected to determinedwhether components need to be replaced. If it is determined that somecomponents of the camera head need to be replaced, at 2332 the faultycomponents will be replaced. After the faulty components have beenreplace at 2332, the camera head may be checked for quality andfunctionality at 2304, and then further processed in accordance to theillustrated system.

FIG. 24 illustrates an embodiment of a system for the manufacture andreprocessing of a surgical camera head or imaging device. Reprocessingmay represent the reclaiming or recycling of a used surgical camera headand any associated accessories or components of said surgical camerahead. At 2404 the assembled camera and any accessories are checked forproper operation, quality and functionality. At 2406 the camera head andany associated accessories may be inserted into a production controlunit or production fixture. The production control unit may check thecondition of the memory within the camera head to determine whether thememory has been formatted to a predetermined operational condition. Ifthe production control unit determines that data and control values inthe memory indicate the camera has been used the memory will be writtenwith a value or values allowing it function at 2408. If the productioncontrol unit determines that data and control values in the memoryindicate that the camera is operational or has not been used, the datain the memory will be recorded and stored in a data base while a valueor values allowing it to function will be written in to the memory ofthe camera head at 2410.

At 2412 the camera head and any associated accessories may be tested forvideo quality and other operational standards. At 2414 the camera headand any associated accessories may be packaged in a biohazard bag orsanitation bag. Such bags may provide the ability to sanitize the camerahead while inside the bag. The sanitation process may include or beaccomplished using Ethylene-Oxide (EO) gas, or other fluid processcorresponding to the properties of said bag or packaging. At 2416 thepackaged camera head and any associated accessories may then besanitized. At 2418 the camera head and any associated accessories may befurther packaged such as in a tray and shipped to an end user. Thecamera head and any associated accessories may be then used for asurgical procedure where during the procedure a camera control unitwrites to the memory in the camera head a usage value at 2420. After usethe camera head and any associated accessories may be placed in a returnshipping container suitable for biohazard shipping at 2422 and shippedto a processing facility or manufacturer at 2424. At 2426 themanufacturer or processing facility may receive the used camera head andany associated accessories, and at 2428 the camera head and anyassociated accessories may be unpackaged and disinfected for furtherprocessing. At 2430 the camera head and any associated accessories maybe inspected to determined whether components need to be replaced. If itis determined that some components of the camera head and any associatedaccessories need to be replaced, at 2432 the faulty components will bereplaced. After the faulty components have been replace at 2432, thecamera head and any associated accessories may be checked for qualityand functionality at 2404, and then further processed in accordance tothe illustrated system.

FIG. 25 illustrates an embodiment of a system for the reprocessing of asurgical camera head or imaging device. Reprocessing may represent thereclaiming or recycling of a used surgical camera head and anyassociated accessories or components of said surgical camera head. At2526 the manufacturer or processing facility may receive the used camerahead and any associated accessories, and at 2528 the camera head and anyassociated accessories may be unpackaged and disinfected for furtherprocessing. At 2530 the camera head and any associated accessories maybe inspected to determined whether components need to be replaced. If itis determined that some components of the camera head and any associatedaccessories need to be replaced, at 2532 the faulty components will bereplaced. After the faulty components have been replace at 2532, thecamera head and any associated accessories may be checked for qualityand functionality at 2504, and then further processed in accordance tothe illustrated system. At 2504 the assembled camera and any accessoriesare checked for proper operation, quality and functionality. At 2506 thecamera head and any associated accessories may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 2508. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 2510. A processor within a computermay be employed to read and record into storage data from said camerahead at 2509 and the data may be stored for later use at 2511.

At 2512 the camera head and any associated accessories may be tested forvideo quality and other operational standards. At 2514 the camera headand any associated accessories may be packaged in a biohazard bag orsanitation bag. Such bags may provide the ability to sanitize the camerahead while inside the bag. The sanitation process may include or beaccomplished using Ethylene-Oxide (EO) gas, or other fluid processcorresponding to the properties of said bag or packaging. At 2516 thepackaged camera head and any associated accessories may then besanitized. At 2518 the camera head and any associated accessories may befurther packaged such as in a tray and shipped to an end user.

FIG. 26 illustrates an embodiment of a system for the reprocessing of asurgical camera head or imaging device and providing updates for saidcamera head or imaging device. Reprocessing may represent the reclaimingor recycling of a used surgical camera head and any associatedaccessories or components of said surgical camera head. At 2626 themanufacturer or processing facility may receive the used camera head andany associated accessories, and at 2628 the camera head and anyassociated accessories may be unpackaged and disinfected for furtherprocessing. At 2630 the camera head and any associated accessories maybe inspected to determined whether components need to be replaced. If itis determined that some components of the camera head and any associatedaccessories need to be replaced, at 2632 the faulty components will bereplaced. After the faulty components have been replace at 2632, thecamera head and any associated accessories may be checked for qualityand functionality at 2604, and then further processed in accordance tothe illustrated system. At 2604 the assembled camera and any accessoriesare checked for proper operation, quality and functionality. At 2606 thecamera head and any associated accessories may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 2608. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 2610. A processor within a computermay be employed to read and record into storage data from said camerahead at 2609 and the data may be stored for later use at 2611.

At 2619 it may be determined whether the operation of the camera head isup to date. At 2613 updates may be created to improve or modify thecamera head. The update may be derived from camera head data stored at2611 and may be responsive to said camera head data. At 2615 the camerahead may be updated. Such updates may be written to the memory of thecamera head and may be done manually, automatically, at the point ofoperation or over a network connection.

At 2612 the camera head and any associated accessories may be tested forvideo quality and other operational standards. At 2614 the camera headand any associated accessories may be packaged in a biohazard bag orsanitation bag. Such bags may provide the ability to sanitize the camerahead while inside the bag. The sanitation process may include or beaccomplished using Ethylene-Oxide (EO) gas, or other fluid processcorresponding to the properties of said bag or packaging. At 2616 thepackaged camera head and any associated accessories may then besanitized. At 2618 the camera head and any associated accessories may befurther packaged such as in a tray and shipped to an end user.

FIG. 27 illustrates an embodiment of a system for the reprocessing of asurgical camera head or imaging device and providing updates for saidcamera head or imaging device. Reprocessing may represent the reclaimingor recycling of a used surgical camera head and any associatedaccessories or components of said surgical camera head. At 2726 themanufacturer or processing facility may receive the used camera head andany associated accessories, and at 2728 the camera head and anyassociated accessories may be unpackaged and disinfected for furtherprocessing. At 2730 the camera head and any associated accessories maybe inspected to determined whether components need to be replaced. If itis determined that some components of the camera head and any associatedaccessories need to be replaced, at 2732 the faulty components will bereplaced. After the faulty components have been replace at 2732, thecamera head and any associated accessories may be checked for qualityand functionality at 2704, and then further processed in accordance tothe illustrated system. At 2704 the assembled camera and any accessoriesare checked for proper operation, quality and functionality. At 2706 thecamera head and any associated accessories may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 2708. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 2710. A processor within a computermay be employed to read and record into storage data from said camerahead at 2709 and the data may be stored for later use at 2711.

At 2719 it may be determined whether the operation of the camera head isup to date. At 2713 updates may be created to improve or modify thecamera head. The update may be derived from camera head data stored at2711 and may be responsive to said camera head data. At 2715 the camerahead may be updated. At 2721 updates may be stored in an update database such that when a camera head is found to be out of date the neededupdates may be selected from the update data base and applied to thecamera head. Such updates may be written to the memory of the camerahead and may be done manually, automatically, at the point of operationor over a network connection.

At 2712 the camera head and any associated accessories may be tested forvideo quality and other operational standards. At 2714 the camera headand any associated accessories may be packaged in a biohazard bag orsanitation bag. Such bags may provide the ability to sanitize the camerahead while inside the bag. The sanitation process may include or beaccomplished using Ethylene-Oxide (EO) gas, or other fluid processcorresponding to the properties of said bag or packaging. At 2716 thepackaged camera head and any associated accessories may then besanitized. At 2718 the camera head and any associated accessories may befurther packaged such as in a tray and shipped to an end user.

FIG. 28 illustrates an embodiment of a system for updating a surgicalcamera head or imaging device. At 2806 the camera head and anyassociated accessories may be inserted into a camera control unit. Thecamera control unit may check the condition of the memory within thecamera head to determine whether the camera head has been updated at2808. If the camera control unit determines that the camera head hasbeen updated the memory will be written with a value or values allowingit function at 2808. If the production control unit determines that dataand control values in the memory indicate that the camera has not beenupdated at 2808, the needed updates will be retrieved from an updatedata base at 2810. A processor within a computer may be employed to readcamera parameters at 2812 and retrieve responsive updates at 2814. Theupdate may be derived from camera head data stored and may be responsiveto said camera head data. At 2815 the camera head may be updated.Updates may be stored in an update data base such that when a camerahead is found to be out of date the needed updates may be selected fromthe update data base and applied to the camera head. Such updates may bewritten to the memory of the camera head and may be done manually,automatically, at the point of operation or over a network connection.At 2818 a value or values may be written to the camera head memorymaking the camera head ready for use.

FIG. 29 illustrates an embodiment of a system for providing updates to asurgical camera head or imaging device. The camera head 2902 may beconfigured to operate in conjunction with a camera control unit 2904.The system may be configured to operate as a network consistent withcurrent network art and technologies as well as future network art andtechnologies that may be used in the future. The system may comprise aserver 2908 configured with communication means for operating over anetwork and communicating with camera control units 2904. The system maycomprise a data base or a plurality of data bases for storing data suchas update data and camera head parameters. The system may comprise anupdate data base 2912 and a camera head data base 2916. The systemcomprise a computer terminal 2920 providing access to the network. Thesystem may use a LAN based method of communication between networkedcomponents and/or it may use wireless communications provide by wirelessmeans 2924.

FIG. 30 illustrates an embodiment of a system and method for themanufacture and reprocessing of a surgical camera head or imagingdevice. Reprocessing may represent the reclaiming or recycling of a usedsurgical camera head and any associated accessories or components ofsaid surgical camera head and may be referred to individually orcollectively herein as an imaging device or a camera head. At 3002 thecamera head components are assembled into a working unit having memory.At 3004 the assembled camera head is checked for proper operation andquality to ensure the assembled camera head passes a pre-determinedminimum standard. At 3006 the camera head may be inserted into aproduction control unit or production fixture. The production controlunit may check the condition of the memory within the camera head todetermine whether the memory has been formatted to a predeterminedoperational condition. If the production control unit determines thatdata and control values in the memory indicate the camera has been usedthe memory will be written with a value or values allowing it functionat 3008. If the production control unit determines that data and controlvalues in the memory indicate that the camera is operational or has notbeen used, the data in the memory will be recorded and stored in a database while a value or values allowing it to function will be written into the memory of the camera head at 3010.

It will be appreciated that the imaging device or other component may beelectronically connected to the test fixture or another component at3006. When components are electronically connected, the components mayauthenticate each other via a communication between the components at3015. For example, the authentication may be between the test fixtureand the imaging device, but any components or devices may beauthenticated with the same procedure or manner, and the authenticationmay be done by complying with certain encryption security protocols. Inan embodiment, the security protocols originate in the imaging device.In an embodiment, the security protocols originate in the test fixture.It will be appreciated that the test fixture may be controlled with aseparate computer. The separate computer may encrypt communicationbetween the test fixture and the separate computer.

It should be appreciated that the communication between the componentsof an embodiment may be encrypted for security and access control. Byencrypting the communication data streams, a user or provider canprotect against tampering and thereby control the quality of thecomponents. It is within the scope of this disclosure to contemplate anymanner of encryption and security currently available, in addition tothose methods that will be developed in the future.

In an embodiment the communication components may have fixed keys thatallow for the transmitting component to insert obfuscating data into thedata stream that will need to be removed by the receiving component ofthe system. Without the key the data would not be readily useable. In anembodiment an imaging device, such as a camera head, may perform theinsertion of the obfuscating data in the data stream. In an embodiment acontrol unit may perform the insertion of the obfuscating data, andtypically both components will perform this roll. In use, both theoutput data and the instructions between components can be encrypted.The keys may be embedded in hardware components, may be firm ware, ormay be software based.

An embodiment may include the use of public and private keys whereineither the control unit or the imaging device is the originator of therespective keys. In an embodiment the public keys may be matched betweenthe components from the outset of operation, or the keys may be derivedon the fly having correspondence values between the components. Anembodiment may comprise a method wherein the encryption originates inthe imaging device. An embodiment may comprise a method wherein theencryption originates in a control unit. An embodiment may compriseadditional components connected to a control unit or imaging device suchas a separate computer, and in such an embodiment all or some of thecommunication between the components may be encrypted.

An embodiment may comprise levels of encryption wherein the keys themselves are encrypted in one level and the data is encrypted in a secondlevel. Additionally, it should be noted that the encryption method maybe updated and changed globally. An update may occur at the time ofreprocessing or the update may occur at the time of use. Such updatesmay be performed locally or may be performed over a network.

In the event of tampering an embodiment may cause the components of thesystem to lock out further use or access. In another embodiment, thecomponents may be configured to self destruct in the event of tampering.

At 3012 the camera head may be tested for video quality and otheroperational standards. The inspection and testing of video quality andother operational standards may include a visual inspection of thevideo/image quality against a known, acceptable image standard. It willbe appreciated that this procedure may be automated, such that if theimage does not meet a certain pre-determined quality standard the onscreen check will return with a “use or no-use” or “go or no-go” onscreen reply or signal.

At 3014 the camera may be packaged in a container, such as a tray,pouch, bag or the like, which may be sterilized along with thecomponents within the container. Such containers may provide the abilityto sanitize the camera head while inside the container. This package orcontainer of components may then be sanitized or sterilized as noted at3016. It will be appreciated that in an embodiment, the componentsincluded in the container, such as a tray, pouch, bag or the like, mayalso include a biohazard bag or sanitation bag. The biohazard bag may beused after an imaging device and related components have been used orotherwise contaminated to return the used or contaminated imagingdevice, along with any components, to a reprocessing center or agent fordisinfection and further reprocessing treatment.

At 3016 the packaged camera head may then be sanitized or sterilized. Itwill be appreciated that there are many methods for sanitizing,sterilizing or otherwise eliminating (killing) transmissible agents,such as fungi, bacteria, viruses, bacterial spores, etc. from surgicaltools and equipment. Such methods are within the scope of thedisclosure. Sterilization may be accomplished using one or more of thefollowing heat, chemicals, irradiation, and high pressure systems.Examples of the sanitization or sterilization methods may includeethylene oxide, gamma radiation, chemicals and autoclave systems.

At 3018, the imaging device, i.e., camera head and any accompanyingcomponents, may be further packaged and shipped to an end user. Thecamera head may then be used for a surgical procedure where during theprocedure a camera control unit writes to the memory in the camera headwhere a use value or use bit may be set at 3020. After use orcontamination, the camera head may be placed in a return shippingcontainer suitable for biohazard shipping at 3022 and shipped to aprocessing facility or manufacturer at 3024. At 3026 the processingfacility or manufacturer may receive the used or otherwise contaminatedcamera head and, at 3028, the camera head may be unpackaged anddisinfected for further processing. It will be appreciated that thedisinfection process is for worker safety where handlers of the used orotherwise contaminated camera head wear protective clothing, such asgloves and gowns. The disinfection process may include chemicaltreatment of the used or otherwise contaminated imaging device or camerahead to meet low-level or other appropriate governmental standards fordisinfection. Various chemicals may be used for the initial disinfectionprocess and may include alcohols, aldehydes, and oxidizing agents. Itwill be appreciated that other disinfection processes may be used toinitially treat the used or otherwise contaminated camera head withoutdeparting from the scope of the disclosure.

At 3030 the camera head may be inspected to determined whethercomponents need to be replaced. If it is determined that some componentsof the camera head need to be replaced, then at 3032 the faultycomponents will be replaced. For example, components that may bereplaced include cables, imaging device connectors, and buttons.However, it should be noted that during this inspection all componentsmay be replaced on an as needed basis. After the faulty components havebeen replaced at 3032, the camera head may be checked for quality andfunctionality at 3004, and then further processed in accordance to theillustrated system.

Referring to FIGS. 31-33 illustrate embodiments of a method and systemfor processing medical electronic imaging devices in accordance with theteachings and principles of the disclosure. In FIG. 31, a method forprocessing an active imaging device intended for use during medicalprocedure is illustrated. In FIG. 32, a method of authenticating anactive imaging device intended for use during medical procedure isillustrated. In FIG. 33, a method of re-setting a control value in animaging device, which may be a passive imaging device, is illustrated.

It will be appreciated that the above system or method for themanufacture and reprocessing of a surgical camera head or imaging devicemay include details relating to the camera head itself or the variousprocesses within each step noted, which may be utilized by any of theembodiments disclosed herein and such details are incorporated into eachof the embodiments.

In the foregoing Detailed Description, various features of thedisclosure are grouped together in a single embodiment for the purposeof streamlining the disclosure. This method of disclosure is not to beinterpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the disclosure reflects, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description by thisreference, with each claim standing on its own as a separate embodimentof the disclosure.

It is to be understood that the above-described arrangements are onlyillustrative of the application of the principles of the disclosure.Numerous modifications and alternative arrangements may be devised bythose skilled in the art without departing from the spirit and scope ofthe disclosure and the disclosure is intended to cover suchmodifications and arrangements. Thus, while the disclosure has beenshown in the drawings and described above with particularity and detail,it will be apparent to those of ordinary skill in the art that numerousmodifications, including, but not limited to, variations in size,materials, shape, form, function and manner of operation, assembly anduse may be made without departing from the principles and concepts setforth herein.

1. A method for processing medical electronic imaging devices intendedfor use during medical procedures, the method comprising: receiving animaging device that comprises: one or more active electronic componentsfrom the group of: field programmable gate array; complex programmablelogic device; micro controller; processor; or memory; an image sensorfor outputting imaging data; and setting a control value in imagingdevice memory to allow the imaging device to operate during a medicalprocedure.
 2. The method of claim 1, wherein the method furthercomprises packaging the imaging device for conveying to a user.
 3. Themethod of claim 2, wherein the method further comprises sterilizing theimaging device for use during a medical procedure.
 4. The method ofclaim 1, wherein the method further comprises electronically connectingsaid imaging device to a test fixture.
 5. The method of claim 4, whereinthe method further comprises authenticating communication between saidtest fixture by complying with encryption security protocols.
 6. Themethod of claim 5, wherein said security protocols originate in saidimaging device.
 7. The method of claim 5, wherein said securityprotocols originate in said test fixture.
 8. The method of claim 4,wherein the method further comprises controlling said test fixture witha separate computer.
 9. The method of claim 8, wherein the methodfurther comprises encrypting communication between said test fixture andsaid separate computer.
 10. The method of claim 1, wherein the methodfurther comprises reading imaging device condition data from saidimaging device; wherein said imaging device condition data comprisesdata derived from one or more of the following active electroniccomponents: field programmable gate array generated condition data;complex programmable logic device generated condition data; microcontroller generated condition data; processor generated condition data;and memory generated condition data.
 11. The method of claim 10, whereinthe method further comprises storing said imaging device data incomputer accessible storage or memory.
 12. The method of claim 4,wherein the method further comprises electronically disconnecting saidimaging device from said test fixture.
 13. A method for updating medicalelectronic imaging devices intended for use during medical procedures,the method comprising: receiving an imaging device that comprises: oneor more active electronic components of the group of: field programmablegate array; complex programmable logic device; micro controller;processor; memory; an image sensor for outputting imaging data;providing updated programming for one or more of said active electroniccomponents; setting a control value in imaging device memory to allowthe imaging device to operate during a medical procedure; andsterilizing the imaging device.
 14. The method of claim 13, wherein themethod further comprises electronically connecting said imaging deviceto a test fixture.
 15. The method of claim 14, wherein the methodfurther comprises authenticating communication between said test fixtureby complying with encryption security protocols.
 16. The method of claim15, wherein said security protocols originate in said imaging device.17. The method of claim 15, wherein said security protocols originate insaid test fixture.
 18. The method of claim 14, wherein the methodfurther comprises controlling said test fixture with a separatecomputer.
 19. The method of claim 18, wherein the method furthercomprises encrypting communication between said test fixture and saidseparate computer.
 20. The method of claim 13, wherein the methodfurther comprises reading imaging device condition data from saidimaging device; wherein said imaging device condition data comprisesdata derived from one or more of the following active electroniccomponents: field programmable gate array generated condition data;complex programmable logic device generated condition data; microcontroller generated condition data; processor generated condition data;memory generated condition data.
 21. The method of claim 20, wherein themethod further comprises storing said imaging device data in computeraccessible storage or memory.
 22. The method of claim 13, wherein themethod further comprises transmitting and receiving said updatedprograming over a network.
 23. The method of claim 13, wherein themethod further comprises connecting said imaging device to a controlunit for use during a surgical procedure and receiving said updatedprogramming from said control unit.
 24. The method of claim 23, whereinthe method further comprises providing said updated programming to saidcontrol unit over a network.
 25. The method of claim 23, wherein themethod further comprises authenticating communication between saidcontrol unit and said imaging device by complying with encryptionsecurity protocols.
 26. The method of claim 25, wherein said securityprotocols originate in said imaging device.
 27. The method of claim 25,wherein said security protocols originate in said control unit.
 28. Themethod of claim 23, wherein the method further comprises controllingsaid control unit with a separate computer.
 29. The method of claim 28,wherein the method further comprises encrypting communication betweensaid control unit and said separate computer.
 30. The method of claim23, wherein the method further comprises reading imaging devicecondition data from said imaging device; wherein said imaging devicecondition data comprises data derived from one or more of the followingactive electronic components: field programmable gate array generatedcondition data; complex programmable logic device generated conditiondata; micro controller generated condition data; processor generatedcondition data; memory generated condition data.
 31. The method of claim30, wherein the method further comprises storing said imaging devicedata in computer accessible storage or memory.
 32. The method of claim30, wherein the method further comprises transmitting and receiving saidimaging device data over a network.
 33. The method of claim 32, whereinthe method further comprises tracking said imaging device by saidimaging device data in order to control imaging devices in circulation.34. A method for processing medical electronic imaging devices intendedfor use during medical procedures, the method comprising: receiving animaging device that comprises: one or more active electronic componentsof the group of: field programmable gate array; complex programmablelogic device; micro controller; processor; memory; an image sensor foroutputting imaging data; electronically connecting said imaging deviceto a test fixture; authenticating communication between the imagingdevice and the test fixture by complying with encryption securityprotocols built into the imaging device; reading imaging devicecondition data from said imaging device; wherein said imaging devicecondition data comprises data derived from one or more of the followingactive electronic components: field programmable gate array generatedcondition data; complex programmable logic device generated conditiondata; micro controller generated condition data; processor generatedcondition data; memory generated condition data; storing said imagingdevice condition data in computer accessible storage or memory; settinga control value in imaging device memory to allow the imaging device tooperate during a medical procedure; and electronically disconnectingsaid imaging device from said test fixture.
 35. The method of claim 34,wherein the method further comprises incrementing a use value in imagingdevice memory representing the number times the imaging device has beenused.
 36. The method of claim 34, wherein the method further compriseswriting configuration instructions to one or more of the followingactive components: field programmable gate array; complex programmablelogic device; micro controller; processor; memory.
 37. The method ofclaim 36, wherein said configuration instructions update the operationof one or more of the following active components: field programmablegate array; complex programmable logic device; micro controller;processor; memory.
 38. The method of claim 34, wherein the methodfurther comprises testing components of the imaging device to testoperational fitness of the components of the imaging device.
 39. Themethod of claim 38, wherein the method further comprises replacingcomponents of the imaging device that failed the operation fitness test.40. The method of claim 34, wherein the method further comprisessterilizing the imaging device.
 41. The method of claim 40, furthercomprising sterilizing the imaging device with ethylene oxide.
 42. Themethod of claim 40, further comprising sterilizing the imaging devicewith gamma radiation.
 43. The method of claim 40, further comprisingsterilizing the imaging device with one or more chemicals chosen fromthe groups of: alcohols, aldehydes, and oxidizing agents.
 44. The methodof claim 34, wherein the method further comprises collecting usedimaging devices from users.
 45. The method of claim 34, wherein themethod further comprises packaging the imaging device in a container forprotecting and retaining the imaging device during storage andtransport.
 46. The method of claim 45, wherein the method furthercomprises collecting used imaging devices in a biohazard container afteruse and made ready for transport according to industry standards forbiohazardous materials.
 47. The method of claim 46, wherein the methodfurther comprises sealing said used imaging devices and said biohazardcontainer in accordance with industry standards.
 48. The method of claim45, wherein the imaging device is packaged in a tray for protecting andretaining the imaging device during storage and transport.
 49. Themethod of claim 45, wherein the imaging device is packaged in a pouchfor protecting and retaining the imaging device during storage andtransport.
 50. The method of claim 34, wherein authenticatingcommunication between said imaging device and test fixture comprises:transmitting a public key from said test fixture to said imaging device;validating said public key; transmitting a private key from said imagingdevice to said test fixture; validating said private key; and allowingelectronic communication between said imaging device and said testfixture.
 51. The method of claim 50 further comprising encrypting saidpublic key before transmission to said imaging device.
 52. The method ofclaim 50 further comprising encrypting said private key beforetransmission to said test fixture.
 53. A method for processing medicalelectronic imaging devices intended for use during medical procedures,the method comprising: receiving an imaging device that comprises: oneor more active electronic components of the group of: field programmablegate array; complex programmable logic device; micro controller;processor; memory; an image sensor for outputting imaging data;sterilizing said imaging device.
 54. A method for processing medicalelectronic imaging devices intended for use during medical procedures,the method comprising: receiving an imaging device that comprises memoryhaving a control value therein and an image sensor for outputtingimaging data; setting a control value in said imaging device memory toallow the imaging device to operate during a medical procedure; andsterilizing said imaging device.
 55. The method of claim 1, wherein themethod further comprises sterilizing the imaging device with ethyleneoxide.
 56. The method of claim 1, wherein the method further comprisessterilizing the imaging device with gamma radiation.
 57. The method ofclaim 1, wherein the method further comprises sterilizing the imagingdevice with one or more chemicals chosen from the groups of: alcohols,aldehydes, and oxidizing agents.